Signal tag detection components, devices, and systems

ABSTRACT

Provided herein are systems, devices, assemblies, and methods for localization of a tag in a tissue of a patient. For example, provided herein are systems, devices, and methods employing a detection component that is attached to or integrated with a surgical device, where the detection component detects a signal from a tag in a patient, where the tag is activated by remote introduction of a magnetic field.

The present application is a divisional of U.S. patent application Ser.No. 14/992,443, filed Jan. 11, 2016, now allowed, which claims priorityto U.S. Provisional Application Ser. No. 62/236,660, filed Oct. 2, 2015,each of which are herein incorporated by reference in its entirety.

FIELD

Provided herein are systems, devices, assemblies, and methods forlocalization of a tag in a tissue of a patient. For example, providedherein are systems, devices, and methods employing a detection componentthat is attached to or integrated with a surgical device, where thedetection component detects a signal from a tag in a patient, where thetag is preferably activated by remote introduction of a magnetic field.

BACKGROUND

A common and serious challenge for many medical procedures is theaccurate localization of treatment areas. For example, the location oflesions, such as tumors that are to undergo treatment, includingsurgical resection, continues to present a challenge to the medicalcommunity. Existing systems are expensive, complex, time-consuming, andoften unpleasant for the patient. Such issues are illustrated by thesurgical treatment of breast lesions.

A common technique used in breast tumor surgery is wire localization ofthe lesions. Precise preoperative localization of some breast lesions isnecessary before removal of the lesion. Wire localization is used tomark the location of a breast abnormality. The procedure ensures greateraccuracy for a breast biopsy or lumpectomy. The surgeon typically usesthe wire as a guide to the tissue that needs to be removed. Wirelocalization is typically conducted in the radiology department of thehospital or surgical center. Mammograms (or in some cases, ultrasoundimages) are taken to show the location of the breast abnormality.Patients are awake during the placement of the wire, but the breasttissue is numbed to reduce or avoid pain from the needle or the wire. Itis possible to feel pressure or pulling sensations during the wireplacement. Once images have been taken, and the tissue has been numbed,the radiologist will use a needle to target the breast abnormality. Thetip of this needle rests in the location that the surgeon needs to findin order to remove the right tissue. A slender wire is threaded downthrough the needle and out of its tip, to lodge at the target tissue.The needle is removed, leaving the wire in place. With the wire inplace, the patient has another mammogram, to check that the tip of thewire is properly positioned. If the wire is not in the correct place,the radiologist will reposition and re-check it, to ensure accurateplacement. When the wire is finally positioned, it will be secured inplace with tape or a bandage. The wire localization procedure can takeabout an hour, and is usually scheduled hours before biopsy orlumpectomy. Thus, the patient must often wait hours for surgery with thewire present in their body and protruding from their skin. The wire isremoved, along with some breast tissue, during surgery. This processtakes many hours, involves multiple imaging steps, and is inconvenientand unpleasant for the patient—as well as being expensive.

A similar type of procedure is done to localize pulmonary nodules priorto resection. In some cases where pulmonary nodules may be difficult tolocate at conventional open surgery or at thoracoscopy, a hook wire,injection of visible dye, or a radionuclide is placed in or around thenodule in an attempt to improve localization prior to removal. Thisprocedure usually takes place in the CT suite prior to the removal ofthe nodule. The patient is then transported to the surgical unit and thesurgeon cuts down on the wire, uses a radionuclide detector, or usesvisual landmarks to localize and remove the nodule.

In other types of surgeries and medical procedures, physicians may havetrouble locating a target prior to removal or manipulation. Examples ofthis include the removal of masses, fluid collections, foreign bodies ordiseased tissues. Other times, placements of catheters or otherpercutaneous procedures are performed either without directvisualization or with the lack of a specific guidance modality.Performing procedures without precise guidance can increase the amountof damage to normal tissues and decrease the patient's functionalstatus.

Percutaneous biopsy is a well-accepted, safe procedure performed invirtually every hospital. Biopsy often entails placement of a co-axialguide needle through which the biopsy device is placed into the target.Many of the lesions that are removed, punctured or manipulated asdescribed above have previously undergone successful percutaneousbiopsy. The placement of the guide needle for biopsy is an opportunityto place a fiduciary or other localizing system without causingadditional tissue trauma than the patient would otherwise undergo.

Many other medical devices and procedures could benefit from improvedtissue localization. These include any procedure or test that isdegraded by any bodily motion such as cardiac motion, respiratorymotion, motion produced by the musculoskeletal system, orgastrointestinal/genitourinary motion. Examples of these includeexternal beam radiation therapy, placement of brachytherapy seeds,imaging tests including but not limited to CT, MRI, fluoroscopy,ultrasound, and nuclear medicine, biopsies performed in any fashion,endoscopy, laparoscopic and thoracoscopic surgery and open surgicalprocedures.

Improved systems and methods are needed for tissue localization formedical procedures.

SUMMARY

Provided herein are systems, devices, assemblies, and methods forlocalization of a tag in a tissue of a patient. For example, providedherein are systems, devices, and methods employing a detection componentthat is attached to or integrated with a surgical device, where thedetection component detects a signal from a tag in a patient, where thetag is activated by remote introduction of a magnetic field. In certainembodiments, the detection component comprises three or more sense coilsto triangulate a tag location and the distance of the tag from thedetection component.

In some embodiments, provided herein are methods for localizing a tissueregion of a patient, comprising: a) placing a remote activating deviceand a patient in proximity to each other, wherein the remote activatingdevice is able to generate a magnetic field, and wherein a tag islocated in a tissue of the patient; and b) localizing the tag in thepatient by generating a magnetic field with the remote activating deviceand detecting a signal from the tag using a detector component, whereinthe detector component comprises at least one sense coil and is attachedto, or integrated with, a surgical device, and wherein the detectorcomponent and remote activating device are separate (e.g., not attachedto, or part of, each other).

In certain embodiments, the at least one sense coil comprises threesense coils that are separated from each other by at least 10 mm (e.g.,at least 10 . . . 15 . . . 20 . . . 25 . . . 30 . . . 40 . . . 50 . . .60 . . . 70 . . . 100 . . . 125 . . . 150 . . . 175 . . . or 200 mm). Inother embodiments, the at least one sense coil comprises three sensecoils arranged in a triangle. In particular embodiments, the triangle isan equilateral triangle or approximately an equilateral triangle.

In particular embodiments, the detector component comprises a housingwith a device-securing component (e.g., an opening in the housing; asnap; tongue and groove; slot; magnetic attachment; etc). In someembodiments, the surgical device is in inserted through thedevice-securing opening such that the housing surrounds a portion of thesurgical device (and such that said surgical device is secured to saiddetection component).

In certain embodiments, the remote activating device, the detectorcomponent, and the surgical device are electrically-linked and/orwirelessly linked to a control unit, wherein the control unit comprisesa processor and control software. In further embodiments, the detectioncomponent comprises a display (e.g., visual, audible, etc.), and whereinthe control unit processes signals from the detection component andprovides data that is displayable on the display. In particularembodiments, the surgical device comprises an electrical surgical devicethat is turned on and off by a user, wherein the control unit allows theremote activating device to generate the magnetic field when theelectrical surgical device is off, and prevents the remote activatingdevice from generating the magnetic field when the electrical surgicaldevice is on (e.g., ensuring that the surgical device and detectionsystem do not interfere with one another). In other embodiments, thesurgical device comprises a power cord, wherein an AC current clamp isattached to the power cord, wherein the AC current clamp iselectrically-linked or wirelessly linked to the control unit, whereinthe AC current clamp senses when the electrical surgical device is on oroff and reports this to the control unit (e.g., such that the controlunit can ensure that the magnetic field from the surgical device andfrom the remote activating device are not active at the same time).

In certain embodiments, the control, unit and/or detection component,has information stored thereon that helps guide the informationdisplayed on the detection component. For example, the information mayinclude data on the type of medical device the detection component isattached to, or what tip or cutting implement is being used with aparticular medical device. In this regard, the precise location of thecutting tip of a medical device and it's relation to the tag (e.g.,distance to the tag) can be communicated to the surgeon (e.g., for veryprecise instructions on cutting tissue). Such information can, forexample, be manually entered into the control unit or detectioncomponent by the user, or automatically found (e.g., by a barcode orother indicator) when a detection component is attached to a particularmedical device.

In certain embodiments, the surgical device comprises an electrocauterydevice, a laser cutting device, a plasma cutting device, or a metalcutting device (e.g., a surgical device manufactured by BOVIE MEDICAL).Additional examples of medical devices that could be attached to, orintegrated with, the detection components of the present disclosure arefound in the following U.S. Pat. Nos. 9,144,453; 9,095,333; 9,060,765;8,998,899; 8,979,834; 8,802,022; 8,795,272; 8,795,265; 8,728,076;8,696,663; 8,647,342; 8,628,524; 8,409,190; 8,377,388; 8,226,640;8,114,181; 8,100,897; 8,057,468; 8,012,154; 7,993,335; 7,871,423;7,632,270; 6,361,532; all of which are herein incorporated by referencein their entireties, and particularly with respect to the hand-heldmedical devices disclosed therein. In some embodiments, the remoteactivating device comprises one or more excitation coils. In furtherembodiments, the remote activating device comprises a pad, and whereinthe pad is placed under the patient or under a bed the patient is on. Inother embodiments, the signal is an irregularity (e.g., interruption orperturbation) in the magnetic field caused by the tag. In otherembodiments, the tag comprises a metal particle (e.g., a ferriteparticle).

In other embodiments, the detector component comprises an electronicscomponent, wherein the electronics component comprises a signalprocessor. In certain embodiments, the detector component comprises anelectronics component, wherein the electronics component comprises: i) aspatial orientation indicator (e.g., visual, audible, etc.), and/or ii)a distance-to-tag indicator (e.g., visual, audible, etc.). In furtherembodiments, the tissue region is selected from the group consisting of:a lesion, a tumor, a breast tumor, a blood vessel, a lymph node, andsentinel node.

In certain embodiments, the detector component comprises a first displayfor presenting distance to tag information (e.g., visual, audible,lights, color, vibration, tactile, etc.), a second display forpresenting vertical axis orientation, such as a preset preferred anglefor approaching a tag in a patient (e.g., a visual, audible, lights,colors, vibration, tactile, etc. display); and/or a third display forpresenting horizontal orientation (e.g., left to right information sothe surgical device can be centered when approaching the tag). In someembodiments, the detector components comprises a plurality of displays(e.g., visual, audible, sensory, etc.) that allow the correct pitch andyaw axes to be employed (to minimize non-target tissue damage), and/orfurther a display that provides distance to tag information. In certainembodiments, the detector component is moved around the patient's bodyprior to surgery to orient the detector component. In certainembodiments, a series of lights and/or sounds are provided on thedetector component that guide the surgeon (e.g., the surgeon attempts tokeep the lights in a center of an “X” series of lights, and/or to keepthe volume of warning sounds off or as low as possible). For example,the detector component may have an array or geometric shape of lights ofdifferent colors that can light up informing the user (e.g., doctor)with regard to location of a tag and/or position of the detectorcomponent (and corresponding surgical instrument), such that the userdoes not have to look away from the surgical field or procedure field.

In some embodiments, the signal comprises: i) a signal detectable bysensory perception; ii) an interruption or perturbation in the magneticfield; or iii) light. In further embodiments, the tag comprises: aradio-frequency identification (RFID) chip; ii) a resonant orself-resonant object; or iii) a metal particle. In other embodiments,the tag has a length, width, and depth, wherein the length is less than10 mm, the width is less than 4 mm, and the depth is less than 4 mm. Inother embodiments, the localizing comprises detecting a change based onintensity, frequency, color, or sound of the signal. In certainembodiments, the tag in the tissue of the patient is detected at a depthof at least 1 mm . . . 10 mm 45 mm 95 mm 125 mm . . . 174 mm . . . or200 mm.

In certain embodiments, the methods further comprise the step ofsurgically removing a tumor from the patient. In additional embodiments,the methods further comprise the step of administering radiation therapyto the patient using the tag as a fiducial. In other embodiments, thepatient comprises a plurality of tags, and wherein the methods furthercomprise the step of determining locations of the plurality of tags tolocalize the tissue region in three dimensional space.

In some embodiments, the tip of the localizing device (e.g., such as asurgical instrument or an electrocautery system) is placed in a specificlocation (e.g., a jig containing a tag at a known distance andorientation from the tip) for calibration. This may require, forexample, entering data into the system to describe the length or shapeof the instrument.

In some embodiments, provided herein are systems comprising: a) adetector component comprising a housing and at least one sense coilinside the housing, wherein the detector component detects a signal froma tag inside a patient; and b) a second component selected from thegroup consisting of: i) a surgical instrument, ii) a remote activatingdevice which generates a magnetic field, iii) a tag that is insertableat a location in a tissue of a patient, and iv) a control unitcomprising a processor and a control software, wherein the control unit,when electrically or wirelessly linked to the detector component,provides data to the detector component.

In certain embodiments, the at least one sense coil comprises threesense coils that are separated from each other by at least 10 mm (e.g.,at least 10 . . . 25 . . . 45 . . . 55 . . . 75 . . . 137 . . . 168 . .. or 200 mm). In other embodiments, the at least one sense coilcomprises at least three sense coils arranged in a triangle. Inparticular embodiments, the triangle is an equilateral triangle orapproximately an equilateral triangle. In certain embodiments, thehousing has a device-securing component (e.g., opening in housing; slot;snap; etc.). In other embodiments, the second component comprises thesurgical device, and wherein the surgical device is in inserted throughthe device-securing opening such that the housing surrounds a portion ofthe surgical device and the surgical device is secured to the housing.In certain embodiments, the surgical instrument comprises a hand-heldsurgical instrument.

In particular embodiments, the tag generates the signal when exposed tothe magnetic field. In further embodiments, the signal is anirregularity in the magnetic field. In other embodiments, the detectioncomponent further comprises a display (e.g., visual, audible, tactile,etc.), and wherein the control unit processes signals from the detectioncomponent and provides the data that is displayable on the visualdisplay. In other embodiments, the data comprises distance to tag dataand/or orientation data. In some embodiments, wherein the control unit,when electrically or wirelessly linked to the detector component and theremote activating component, causes the remote activating device togenerate the magnetic field when the electrical surgical device is off,and prevents the remote activating device from generating the magneticfield when the electrical surgical device is on. In other embodiments,the surgical device comprises a power cord, wherein an AC current clampis attached to the power cord.

In some embodiments, the surgical device comprises an electrocauterydevice, a laser cutting device, a plasma cutting device, or a metalcutting device. In other embodiments, the remote activating devicecomprises an excitation coil. In some embodiments, the remote activatingdevice comprises a pad or other generally flat component.

In certain embodiments, the tag comprises a metal particle (e.g.,ferrite particle). In some embodiments, the detector component comprisesan electronics component, wherein the electronics component comprises asignal processor. In some embodiments, the detector component comprisesan electronics component, wherein the electronics component comprises:i) a visual spatial orientation indicator, and/or ii) a distance-to-tagindicator. In certain embodiments, the tag has a length, width, anddepth, wherein the length is less than 10 mm, the width is less than 4mm, and the depth is less than 4 mm.

In some embodiments, provided herein are detector components comprising:i) a housing having a device-securing component (e.g., opening inhousing; snap; slot; etc.); and ii) at least one sense coil inside thehousing, wherein the detector component detects a signal from a taginside a patient. In further embodiments, the at least one sense coilcomprises three sense coils that are separated from each other by atleast 10 mm (e.g., 10 mm 50 . . . 200 mm). In certain embodiments, theat least one sense coil comprises at least three sense coils (e.g.,arranged in a triangle, or otherwise able to triangulate the positionand distance of tag). In other embodiments, the triangle is anequilateral triangle or approximately an equilateral triangle. Infurther embodiments, the detector component further comprises anelectronics component, wherein the electronics component comprises asignal processor. In other embodiments, the detector component furthercomprises an electronics component, wherein the electronics componentcomprises: i) a spatial orientation indicator, and/or ii) adistance-to-tag indicator.

In certain embodiments, provided herein are detector componentscomprising: i) a housing; and ii) at least three sense coils inside thehousing (e.g., arranged in a triangle or otherwise able to triangulatethe position and distance of the tag) wherein the detector component isable to detect a signal from a tag inside a patient. In someembodiments, the three sense coils that are separated from each other byat least 10 mm (e.g., 10 mm . . . 100 mm . . . 200 mm). In otherembodiments, the triangle is an equilateral triangle or approximately anequilateral triangle. In additional embodiments, the detector componentfurther comprises an electronics component, wherein the electronicscomponent comprises a signal processor. In certain embodiments, thedetector component further comprises an electronics component, whereinthe electronics component comprises: i) a spatial orientation indicator,and/or ii) a distance-to-tag indicator. In some embodiments, the housinghas a device-securing opening therein.

In particular embodiments, provided herein are devices comprising: a) ahand-held surgical instrument, and b) a detector component attached to,or integrated with, the hand-held surgical instrument, wherein thedetector component comprises a housing and at least one sense coilinside the housing, wherein the detector component is able to detect anirregularity in a magnetic field.

In some embodiments, the at least one sense coil comprises three sensecoils that are separated from each other by at least 10 mm . . . 30 mm .. . 50 mm . . . or 200 mm. In other embodiments, the at least one sensecoil comprises three sense coils arranged in a triangle or otherarrangement able to triangulate the location of a tag in a patient. Incertain embodiments, the triangle is an equilateral triangle orapproximately an equilateral triangle. In other embodiments, thedetector component comprises a housing with a device-securing component(e.g., opening therein, snap, slot, or other connector) and wherein thesurgical device is attached to the detection component via thedevice-securing component (e.g., surgical device is in inserted throughthe opening such that the housing surrounds a portion of the surgicaldevice). In other embodiments, the hand-held surgical instrumentcomprises an electrocautery device, a laser cutting device, a plasmacutting device, or a metal cutting device. In additional embodiments,the hand-held surgical instrument comprises a power cord, and wherein anAC current clamp is attached to the power cord. In other embodiments,the detector component comprises an electronics component, wherein theelectronics component comprises a signal processor. In furtherembodiments, the detector component comprises an electronics component,wherein the electronics component comprises: i) a spatial orientationindicator (e.g., display), and/or ii) a distance-to-tag indicator.

In some embodiments, the tag comprises a self-resonant object (e.g., asmall ferrite core with a wound inductor). The wound inductor possessesinter-winding capacitance that in combination with the inductanceproduces a high frequency resonant circuit. In some embodiments, the tagcomprises a resonant object (e.g., self-resonant object is equipped witha chip capacitor to produce resonance at a prescribed frequency). Insome embodiments, the tag comprises a resonant or self-resonant objectwith a diode. A diode in combination with LC circuit produces asub-harmonic frequency when immersed in a magnetic field of sufficientstrength (imposed voltage exceeds the diode's band-gap potential). Insome embodiments, the tag comprises a resonant object or self-resonantobject with an active modulator (e.g., integrated circuit amplitudemodulates resonant circuit). Detection occurs similar to a full duplex(FDX) radio frequency identification (RFID) except that the modulationpattern is a simple sub-harmonic rather than a coded binary pattern.

In some embodiments, the tag is configured for single-use. In some suchembodiments, a tag can be disabled or deactivated (e.g., like an EAStag). This is particularly useful where multiple tags are used in aprocedure where individual tags are turned off to make detection ofother tags easier (e.g., to avoid or reduce interference betweenmultiple tags). In some embodiments, a burst of energy from an externaldevice is used to disable or deactivate a tag. In other embodiments, thetag has an internal control component that, upon receiving instructionfrom an external device, turns the tag on or off (e.g., the tag stops“talking” temporarily or permanently).

In some embodiments, the tag has an exterior length, width, and depth,wherein the length is 30 mm or less (e.g., 20 mm or less, . . . , 10 mmor less, . . . , 9 mm or less, . . . , 8 mm or less, . . . , 5 mm orless, . . . , 3 mm or less, . . . , etc.), the width is 5 mm or less(e.g., 4 mm or less, . . . , 3 mm or less, . . . , 2 mm or less, . . . 1mm or less, . . . 0.5 mm or less, . . . , etc.), and the depth is 5 mmor less (e.g., 4 mm or less, . . . , 3 mm or less, . . . , 2 mm or less,. . . 1 mm or less, . . . 0.5 mm or less, . . . , etc.).

In some embodiments, the tag is contained in a housing. In someembodiments, no housing is employed. In some embodiments, the housingcomprises a biocompatible material. In some embodiments, the housingprovides a liquid and/or gas resistant barrier separating the signalsource from the exterior of the housing. In some embodiments, thehousing is small, permitting administration of the tag through a needle,cannula, endoscope, catheter, or other medical device. In some suchembodiments, the housing has an exterior length, width, and depth,wherein the length is 30 mm or less (e.g., 20 mm or less, . . . 10 mm orless, . . . 9 mm or less, . . . 8 mm or less, . . . 5 mm or less, . . .3 mm or less, . . . , etc.), the width is 5 mm or less (e.g., 4 mm orless, . . . 3 mm or less, . . . 2 mm or less, . . . 1 mm or less, . . .0.5 mm or less, . . . , etc.), and the depth is 5 mm or less (e.g., 4 mmor less, . . . 3 mm or less, . . . 2 mm or less, . . . 1 mm or less, . .. 0.5 mm or less, . . . , etc.). The housing can be of any desiredshape. In some embodiments, the housing is cylindrical along the lengthaxis. In some embodiments, the housing is shaped like a grain of rice(e.g., cylindrical with rounded ends). In some embodiments, the housingis shaped like a pillar (e.g., cylindrical with flat ends). In someembodiments, the housing is polygonal along the length axis (e.g.,triangular, square, rectangular, trapezoidal, pentagonal, etc., incross-section). In some embodiments the housing has struts or otherfasteners to keep the device in place, avoiding migration in tissue.These struts may deploy upon placement in tissue. In some embodimentsthe fastener may be a biocompatible material that bonds with surroundingtissue.

In some embodiments, the housing is a single uniform componentsynthesized around the interior components of the tag. In otherembodiments, the housing is made of two or more separate segments thatare sealed together after introduction of the interior components of thetag. In some embodiments, the tag is completely or partially covered ina coating. In some embodiments, the coating comprises a biocompatiblematerial (e.g., parylene-C, etc.).

In some embodiments, the tag does not comprise any power source. Forexample, in some embodiments, the signal is generated from the signalsource in response to a magnetic field as the activation event (i.e.,electromagnetic induction).

In some embodiments, the tag comprises a radio-frequency identification(RFID) chip (e.g., in a housing). In some embodiments, the RFID chipcomprises a radio-frequency electromagnetic field coil that modulates anexternal magnetic field to transfer a coded identification number and/orother coded information when queried by a reader device. In someembodiments, the RFID chip collects energy from an EM field generated bythe activating device (or other device) and then acts as a passivetransponder to emit microwaves or UHF radio waves. In some embodiments,a reader (which can be part of the activation device or another device)sends a signal to the RFID chip and reads its response. In someembodiments, the reader is a hand-held device that comprises a computersystem RFID software or RFID middleware. In some embodiments, the RFIDchip is read-only. In other embodiments, it is read/write. Thetechnology is not limited by the nature of the information provided bythe RFID chip. In some embodiments, the information includes a serialnumber, lot or batch number, time information (e.g., production date;surgery date; etc.); patient-specific information (e.g., name, familyhistory, drugs taken, allergies, risk factors, procedure type, gender,age, etc.); procedure-specific information; etc. The technology is notlimited by the frequency used. In some embodiments, the RFID frequencyis in the 120-150 kHz band (e.g., 134 kHz), the 13.56 MHz band, the 433MHz band, the 865-868 MHz band, the 902-928 MHz band, the 2450-5800 MHzband, or the like. In some embodiments, the RFID chip is incorporatedwith browser-based software to increase its efficacy. In someembodiments, this software allows for different groups or specifichospital staff, nurses, and patients to see real-time data relevant tothe tag, procedure, or personnel. In some embodiments, real-time data isstored and archived to make use of historical reporting functionalityand to prove compliance with various industry regulations. In someembodiments, the RFID chip reports sensor data (e.g., temperature,movement, etc.). In some embodiments, the RFID chip contains or collectsinformation that is read at a later time (after surgery). In someembodiments, information is reviewed during surgery. For example, amessage may be provided to the surgeon (e.g., “the chip is just to theleft of the tumor”) to assist in guiding the surgeon (e.g., optimizingremoval of a tumor with the appropriate margins).

In some embodiments, the tag consists of or consists essentially of thesignal source and the housing or the signal source, the housing, and theRFID chip. In some embodiments, the tag (e.g., via the chip) emits anultrasound signal (e.g., gray scale, spectral, or color Doppler) suchthat the signal is detectable by an ultrasound probe or a hand-heldDoppler unit.

In some embodiments, a tag is heated during a procedure (e.g., viaexposure to an external energy source). In some such embodiments,heating may be used to assist in coagulation or precoagulation of tissueor to provide thermotherapy (see e.g., U.S. Pat. Publ. No. 2008/0213382,herein incorporated by reference in its entirety). Heating may also beused to improve the efficacy of radiation therapy.

In some embodiments, a magnetic field and/or other sensing modality isprovided by a remote activating device. In some embodiments, the remoteactivating device causes the activation event when in proximity (e.g.,within a meter, . . . 0.5 meters, . . . 0.3 meters, . . . 0.2 meters, .. . 0.1 meters, . . . 0.05 meters, . . . , etc.) to the tag. In someembodiments, the intensity of the signal increases with closer proximityof the activating device and the tag. In some embodiments, the tag doesnot comprise any energy storage devices (e.g., battery, capacitor,etc.).

In some embodiments, the remote activating device employs an unmodulatedconstant frequency activation (i.e., the activation signal has constantamplitude and frequency). In some embodiments, the tag produces anirregularity in the activation field. The sensing method detects a shiftin either amplitude or frequency induced by the tag's presence. In someembodiments, the remote activating device employs an unmodulated sweptfrequency (i.e., the activation signal has constant amplitude and sweptfrequency between two endpoints). Such devices find use withresonant-type tags such that a detectable change in the activationsignal's amplitude occurs when the transmitted frequency coincides withthe tag's resonant frequency.

In some embodiments, the remote activating device employs a pulsedfrequency (i.e., the activation signal comprises brief excitation pulsesat a periodic frequency, which may be comprised of two closely-relatedfrequencies whose sum or difference is the response frequency of thetag). The pulsed activation produces a post-pulse sinusoidal decaysignal. A tag alters the characteristic of the decaying signal, eitherin amplitude or time. In some embodiments, the remote activating devicecomprises a hand-held component. In some embodiments, the hand-heldcomponent is lightweight to allow a surgeon to hold and manipulate thecomponent over the course of a procedure (e.g., 5 kg or less, 4 kg orless, 3 kg or less, 2 kg or less, 1 kg or less, 0.5 kg or less, 0.25 kgor less, or any range therein between, e.g., 0.5 to 5 kg, 1 to 4 kg,etc.). In some embodiments, the hand-held component is shaped like awand, having a proximal end that is held by the physician and a distalend that is pointed towards the treated subject or tissue harboring thetag. In some embodiments, the hand-held component is shaped like anotoscope, having a distal end that terminates at an angle (e.g., rightangle) from the body of the component. In some embodiments, the remoteactivating device comprises an antenna that generates a magnetic field.In some embodiments, the remote activating device has only a singleantenna (i.e., is monostatic). In some embodiments, the remoteactivating device has only two antennas (i.e., is bistatic).

In some embodiments, the magnetic field of the remote activating deviceis controlled by a processor running a computer program. In someembodiments, the remote activating device comprises a display or userinterface that allows the user to control the remote activating deviceand/or monitor its functions while in use. In some embodiments, theremote activating device provides a visual, audio, numerical, symbol(e.g., arrows), textual, or other output that assists the user inlocating the tag or identifying the distance to or direction of the tagfrom the remote activating device.

In some embodiments, the detection component comprises a series oflights (LEDs) (e.g., 5 lights) which are lit to indicate proximity,distance, or direction to the tag. In some embodiments, the user hascontrol over the strength of the magnetic field produced by the remoteactivating device. In some embodiments, internal algorithms embodied inthe software control the magnetic field. In some embodiments, the usermay select one or more algorithms from a menu. In some embodiments,algorithms reduce or increase the sensitivity of the remote activatingdevice based on its distance from the tag. In certain embodiments, thedisplay on the detection component displays numerals (e.g., numbers onan LCD screen for reporting distance).

In some embodiments, an image from an imaging component is associatedwith data collected by the detection component. In some suchembodiments, a user display provides an image of the tissue from thesubject (e.g., obtained from MRI, CT, ultrasound, or other imagingmodality) and overlays information about the location of the tag, thedetection component, and/or a surgical tool used by the surgeon.

In some embodiments, the remote activating device comprises anexcitation coil. In some embodiments, the excitation coil is provided ina patch or pad that is placed on the patient or on the operating table.In some embodiments, where the system is used to locate breast tumors,the patch encircles the treated breast or is placed otherwise near thebreast. In some embodiments, a pad containing the excitation coil isplaced beneath the patient. In such embodiments, a large coil ormultiple coils are employed. The excitation coil(s) may comprise orconsist of several turns of a flat conductor patterned on a dielectricsubstrate, or may comprise or consist of magnet wire wound around asuitable mandrel; the coil is powered by an external frequency source,and the magnetic field emanating from the coil penetrates the patient'sbody to excite the tag, whose emissions (in some embodiments at a higherharmonic of the excitation or in some temporal or spectral combinationunique to the tag) are detected by the detection component.

In some embodiments, the excitation coil or coils are contained in abelt that is placed around the subject or a portion of the subject. Insome embodiments, the external excitation coil may further be used forother aspects of the patient case, such as for radiotherapy. In someembodiments, the remote activating device emits light (e.g., laserlight). In some embodiments, remote activating device is configured forsingle use (e.g., is disposable).

In some embodiments, the detection component is attached to orintegrated with a surgical device, such as an electrosurgical device(e.g., electrocautery device such as a BOVIE device), cutting device,ablation device, or the like. A single housing may contain allcomponents of the detection component and the surgical device.Alternatively, a bracket or other component is used to connect acomponent of a detection component to a surgical device. In someembodiments, a holder is used to mount both the electrosurgical deviceand the detection component together. In some embodiments, the detectioncomponent or a component thereof is attached to or integrated intoanother type of medical device that is used in the desired surgicalprocedure (e.g., clamps, endoscopes, bronchoscopes, extendedbronchoscopes, dissection tools, lasers, laparoscopes, thoracoscopes,etc.).

Further provided herein are systems comprising the above tags, remoteactivating devices, and detection component. For example, systems maycomprise the tag and detection component. Systems may further compriseother hardware (e.g., RFID reader), software, instructions, medicaldevices (e.g., cutting tools, imaging devices, tissue ablation devices,syringes, introduction needles/cannulas/endoscopes, sterilizationcomponents, etc.), pharmaceuticals, or other components useful,necessary, or sufficient for conducting a procedure with the tag. Insome embodiments, the system comprises a computer that provides commandand control functions for the tag and/or detection component. In someembodiments, the software collects and analyzes procedure data,information from an RFID chip, or other information generated during aprocedure using the tag. In some embodiments, a computer comprises adisplay for displaying information to the treating physician,radiologist, patient, or other personnel involved in a procedure.

The tag is not limited to placement within a particular body region,body part, organ, or tissue. For example, in some embodiments, the tagis placed in the cephalic, cervical, thoracic, abdominal, pelvic, upperextremities, or lower extremities region of the body. In someembodiments, the tag is placed within an organ system, such as theskeletal system, muscular system, cardiovascular system, digestivesystem, endocrine system, integumentary system, urinary system,lymphatic system, immune system, respiratory system, nervous system orreproductive system. In some embodiments, the tag is placed within anorgan. Such organs may include the heart, lungs, blood vessels,ligaments, tendons, salivary glands, esophagus, stomach, liver,gallbladder, pancreas, intestines, rectum, anus, hypothalamus, pituitarygland, pineal gland, thyroid, parathyroids, adrenal glands, skin, hair,fat, nails, kidneys, ureters, bladder, urethra, pharynx, larynx,bronchi, diaphragm, brain, spinal cord, peripheral nervous system,ovaries, fallopian tubes, uterus, vagina, mammary glands, testes, vasdeferens, seminal vesicles, and prostate. In some embodiments, the tagis placed within tissues, such as connective, muscle, nervous, andepithelial tissues. Such tissues may include cardiac muscle tissue,skeletal muscle tissue, smooth muscle tissue, loose connective tissue,dense connective tissue, reticular connective tissue, adipose tissue,cartilage, bone, blood, fibrous connective tissue, elastic connectivetissue, lymphoid connective tissue, areolar connective tissue, simplesquamous epithelium, simple cuboidal epithelium, simple columnarepithelium, stratified epithelium, pseudostratified epithelium, andtransitional epithelium.

In some embodiments, the tissue region where the tag is locatedcomprises a lesion. In some embodiments, the lesion is a tumor or atissue region identified as being at risk for forming a tumor. In someembodiments, the lesion is fibrotic tissue. In some embodiments, thelesion is an inflamed or infected region. In some embodiments, the tagmay be placed within a lumen to detect function or other process of theorgan or provide localizing information. For example, the tag could beswallowed, or placed into a hollow organ via endoscopy. In someembodiments, the tissue region is healthy tissue.

In some embodiments, the tag is placed within a solid tumor. Examples ofsolid tumors into which the tag may be placed include carcinomas,lymphomas, and sarcomas, including, but not limited to, aberrantbasal-cell carcinoma, acinar cell neoplasms, acinic cell carcinoma,adenocarcinoma, adenoid cystic carcinoma, adenoid/pseudoglandularsquamous cell carcinoma, adnexal neoplasms, adrenocortical adenoma,adrenocortical carcinoma, apudoma, basal cell carcinoma, basaloidsquamous cell carcinoma, carcinoid, cholangiocarcinoma, cicatricialbasal-cell carcinoma, clear cell adenocarcinoma, clear cellsquamous-cell carcinoma, combined small cell carcinoma, comedocarcinoma,complex epithelial carcinoma, cylindroma, cystadenocarcinoma,cystadenoma, cystic basal-cell carcinoma, cystic neoplasms, ductalcarcinoma, endometrioid tumor, epithelial neoplasms, extramammaryPaget's disease, familial adenomatous polyposis, fibroepithelioma ofPinkus, gastrinoma, glucagonoma, Grawitz tumor, hepatocellular adenoma,hepatocellular carcinoma, hidrocystoma, Hurthle cell, infiltrativebasal-cell carcinoma, insulinoma, intraepidermal squamous cellcarcinoma, invasive lobular carcinoma, inverted papilloma,keratoacanthoma, Klatskin tumor, Krukenberg tumor, large cellkeratinizing squamous cell carcinoma, large cell nonkeratinizingsquamous cell carcinoma, linitis plastica, liposarcoma, lobularcarcinoma, lymphoepithelial carcinoma, mammary ductal carcinoma,medullary carcinoma, medullary carcinoma of the breast, medullarythyroid cancer, micronodular basal-cell carcinoma, morpheaformbasal-cell carcinoma, morphoeic basal-cell carcinoma, mucinouscarcinoma, mucinous cystadenocarcinoma, mucinous cystadenoma,mucoepidermoid carcinoma, multiple endocrine neoplasia, neuroendocrinetumor, nodular basal-cell carcinoma, oncocytoma, osteosarcoma, ovarianserous cystadenoma, Paget's disease of the breast, pancreatic ductalcarcinoma, pancreatic serous cystadenoma, papillary carcinoma, papillaryhidradenoma, papillary serous cystadenocarcinoma, papillary squamouscell carcinoma, pigmented basal-cell carcinoma, polypoid basal-cellcarcinoma, pore-like basal-cell carcinoma, prolactinoma, pseudomyxomaperitonei, renal cell carcinoma, renal oncocytoma, rodent ulcer, serouscarcinoma, serous cystadenocarcinoma, signet ring cell carcinoma,signet-ring-cell squamous-cell carcinoma, skin appendage neoplasms,small cell carcinoma, small cell keratinizing squamous cell carcinoma,somatostatinoma, spindle cell squamous cell carcinoma, squamous cellcarcinoma, squamous cell lung carcinoma, squamous cell thyroidcarcinoma, superficial basal-cell carcinoma, superficial multicentricbasal-cell carcinoma, syringocystadenoma papilliferum, syringoma,thymoma, transitional cell carcinoma, verrucous carcinoma, verrucoussquamous cell carcinoma, VlPoma, and Warthin's tumor.

In some embodiments, placing the tag comprises the steps of inserting anintroduction device into the subject and introducing the tag through theintroduction device into the subject. In some embodiments, theintroduction device is a needle, catheter, cannula, or endoscope. Insome embodiments, the tag is forced through the introduction device(e.g., via physical force, pressure, or any other suitable technique)and released into the subject at the distal end of the introductiondevice. After the tag is placed, the introduction device is withdrawn,leaving the tag at the desired location with the subject. In someembodiments, the introduction of the tag is guided by imagingtechnology.

In some embodiments, multiple tags are placed into the subject. The tagsmay be of identical type or may differ (e.g., differ in signal type).The tags may be placed in proximity to one another or at distantlocations. Multiple tags are used, in some embodiments, to triangulatethe location intended for medical intervention.

In some embodiments, the tags are further used as fiducials forradiotherapy (or other targeted therapy). The location of the tags isidentified with an external reader and used to place, for example, laserlight on the skin surface exactly where the chip is located. Thiseliminates the need to use X-ray, CT, or fluoroscopy to see thelocations of the fiducials. This also decreases or eliminates the needto put skin markers (e.g., tattoos) on patients. This also helps inrespiratory compensation as the fiducial moves up and down with a tumorin the lung or abdomen. Therefore, one can conduct real-time radiationonly when the tumor is in the correct position and decrease damage tothe background tissue (e.g., avoid burning a vertical stripe in thepatient as the tumor moves up and down). The use as fiducials fordirector therapy (e.g., radiation therapy) also all enhancestriangulation as depth information (based on signal strength) assists inlocalization of the tumor to minimize collateral damage.

In certain embodiments, a fiduciary or localizing system is placedduring an endoscopic procedure. For example, during colonoscopy,gastroscopy, duodenoscopy, cystoscopy, etc., a fiducial could beattached to a polyp or other mass. This fiducial is then localizedduring a subsequent procedure such as, for example, a laparoscopic colonresection or other procedure.

In some embodiments, the tag comprises a fixing component on the outersurface (e.g., of the housing, if present) to anchor the tag in thedesired location. In some embodiments, the fixing component is a hook,barb, or other physical extension. In some embodiments, the fixingcomponent is deployable upon placement. In some embodiments, the fixingcomponent is a textured surface. In some embodiments, the fixingcomponent is an adhesive.

It will be appreciated that the systems and methods described herein maybe applied to other uses, including non-medical uses. The technologyfinds use in any situation where localization of a tag is desired,including, but not limited to, surgical procedures, diagnosticprocedures, veterinary procedures, food analysis, industrialapplications, and environmental applications.

Definitions

As used herein, the terms “processor” and “central processing unit” or“CPU” are used interchangeably and refer to a device that is able toread a program from a computer memory (e.g., ROM or other computermemory) and perform a set of steps according to the program.

As used herein, the terms “computer memory” and “computer memory device”refer to any storage media readable by a computer processor. Examples ofcomputer memory include, but are not limited to, RAM, ROM, computerchips, digital video discs (DVD), compact discs (CDs), hard disk drives(HDD), optical discs, and magnetic tape. In certain embodiments, thecomputer memory and computer processor are part of a non-transitorycomputer (e.g., in the control unit). In certain embodiments,non-transitory computer readable media is employed, where non-transitorycomputer-readable media comprises all computer-readable media with thesole exception being a transitory, propagating signal.

As used herein, the term “computer readable medium” refers to any deviceor system for storing and providing information (e.g., data andinstructions) to a computer processor. Examples of computer readablemedia include, but are not limited to, DVDs, CDs, hard disk drives,magnetic tape and servers for streaming media over networks, whetherlocal or distant (e.g., cloud-based).

As used herein, the term “in electronic communication” refers toelectrical devices (e.g., computers, processors, etc.) that areconfigured to communicate with one another through direct or indirectsignaling. For example, a conference bridge that is connected to aprocessor through a cable or wire, such that information can passbetween the conference bridge and the processor, are in electroniccommunication with one another. Likewise, a computer configured totransmit (e.g., through cables, wires, infrared signals, telephonelines, airwaves, etc.) information to another computer or device, is inelectronic communication with the other computer or device.

As used herein, the term “transmitting” refers to the movement ofinformation (e.g., data) from one location to another (e.g., from onedevice to another) using any suitable means.

As used herein, the term “subject” or “patient” refers to any animal(e.g., a mammal), including, but not limited to, humans, non-humanprimates, companion animals, livestock, equines, rodents, and the like,which is to be the recipient of a particular treatment. Typically, theterms “subject” and “patient” are used interchangeably herein inreference to a human subject.

As used herein, the term “subject/patient suspected of having cancer”refers to a subject that presents one or more symptoms indicative of acancer (e.g., a noticeable lump or mass) or is being screened for acancer (e.g., during a routine physical). A subject suspected of havingcancer may also have one or more risk factors. A subject suspected ofhaving cancer has generally not been tested for cancer. However, a“subject suspected of having cancer” encompasses an individual who hasreceived an initial diagnosis (e.g., a CT scan showing a mass) but forwhom the stage of cancer is not known. The term further includes peoplewho once had cancer (e.g., an individual in remission).

As used herein, the term “biopsy tissue” refers to a sample of tissue(e.g., breast tissue) that is removed from a subject for the purpose ofdetermining if the sample contains cancerous tissue. In some embodiment,biopsy tissue is obtained because a subject is suspected of havingcancer. The biopsy tissue is then examined (e.g., by microscopy; bymolecular testing) for the presence or absence of cancer.

As used herein, the term “sample” is used in its broadest sense. In onesense, it is meant to include a specimen or culture obtained from anysource, as well as biological and environmental samples. Biologicalsamples may be obtained from animals (including humans) and encompassfluids, solids, tissues, and gases. Biological samples include tissue,blood products, such as plasma, serum and the like. Such examples arenot however to be construed as limiting the sample types applicable tothe present invention.

DESCRIPTION OF DRAWINGS

FIG. 1A shows an exemplary medical device (electrocautery device) fromU.S. Pat. No. 8,998,899, which is herein incorporated by reference.

FIG. 1B shows an exemplary device/assembly of the present disclosure,showing a detection component attached to the medical device of FIG. 1A.

FIG. 2 shows an exemplary detection component (20) having a detectioncomponent housing (25) which contains three sense coils (30) and anelectronics component (35). The housing (25) also has a device-securingopening (40) therein.

FIG. 3 shows an exemplary detection component-medical device assembly(21), wherein the surgical device is inserted through thedevice-securing opening of the detection component housing.

FIG. 4 shown a photograph of an exemplary detection component-medicaldevice assembly.

FIG. 5 shows a photograph of an exemplary detection component with avisual display (45) located therein.

FIG. 6 shows a photograph of a side view of an exemplary detectioncomponent-medical device assembly.

FIG. 7, which is not to scale, shows a patient with a tag (100) insertednext to a solid tumor (110), wherein the patient is laying on top of aremote activating device (50). Also shown is a detectioncomponent-surgical device assembly (21).

FIG. 8 shows a control unit (60) that is attached to both a remoteactivating device (50) and a detection component-medical device assembly(21). The remote activating device (50) has an excitation coil (55). Thedetection component-surgical device assembly (21) is attached to thecontrol unit (60) via connection wire (65).

DETAILED DESCRIPTION

Provided herein are systems, devices, assemblies, and methods forlocalization a tag in a tissue of a patient. For example, providedherein are systems, devices, and methods employing a detection componentthat is attached to or integrated with a surgical device, where thedetection component can detect a signal from a tag in a patient, wherethe tag is activated by remote introduction of a magnetic field. Incertain embodiments, the detection component comprises three sense coilsarranged in a triangle.

Systems and Devices

FIG. 1A shows an exemplary medical device (electrocautery device) fromU.S. Pat. No. 8,998,899, which is herein incorporated by reference inits entirety. Specifically, FIG. 1B shows a surgical instrument (10),with a housing (2) having a coagulation button (16) and a cut modebutton (14). The tip of the surgical instrument (10) is attached toelectrode (8), that may be used for cutting and/or cauterizing tissue.The surgical device (10) is attached to an electrical surgical unit (11)via connector (12). The electrical surgical unit (11) provides power andvarious controls. FIG. 1B shows an exemplary device/assembly of thepresent disclosure, showing a detection component (20) attached to themedical device of FIG. 1A. The detection component (20) is shown withtwo sense coils (30) inside housing (25). Also inside the house (25) iselectronics component (35) which may, for example, be used to processthe signals received by sense coils (30), and/or provide a display to auser regarding distance to a tag embedded in a patient.

FIG. 2 shows an exemplary detection component (20) having a detectioncomponent housing (25) (e.g., composed of plastic or other material)which contains three sense coils (30) (which are arranged in a triangleconfiguration) and an electronics component (35). The housing (25) alsohas a device-securing opening (40) therein, which allows a medicaldevice to be inserted and secured in place.

FIG. 3 shows an exemplary detection component-medical device assembly(21), wherein the surgical device is inserted through thedevice-securing opening of the detection component housing. In thisassembly, for example, the detection component is positioned such thatit does not interfere with a user (e.g., surgeon) using the medicaldevice in its normal mode of use. In this figure, the detectioncomponent is position distal to the cutting and/or cauterizing end ofthe medical device, and away from the buttons used during operation.

FIG. 4 shown a photograph of an exemplary detection component-medicaldevice assembly in the hand of a user. Again, the detection component ispositioned such that the user is free to use the device and operate thebuttons and cutting/cauterizing tip in a normal fashion.

FIG. 5 shows a photograph of an exemplary detection component with avisual display (45) located therein. A visual display may be used toinform the user (e.g., a surgeon) how far the tag (in the patient) isfrom the device, and may also be used to help keep the surgical deviceoriented in the correct planes (e.g., to avoid unnecessary cutting orcauterizing with the medical device). In certain embodiments,orientation and/or distance are indicated with a number of lights (e.g.,5 LED lights).

FIG. 6 shows a photograph of a side view of an exemplary detectioncomponent-medical device assembly.

FIG. 7 shows a patient with a tag (100) inserted next to a solid tumor(110) (e.g., in breast tissue of the patient), wherein the patient islaying on top of a remote activating device (50), which is shown as aflat pad. Also shown is a detection component-surgical device assembly(21). The remote activating device may also be positioned closer to thetag (100) (e.g., by being placed on the abdomen), or placed further away(e.g., under the table or mattress the patient is supported on). Incertain embodiments, the remote activating device (50) generates amagnetic field that passed through the patient's body, striking the tag,which causes a reflection or irregularity in the magnetic field. Suchreflection or irregularity is detected by the detection component. Avisual display (e.g., on the detection component or elsewhere) thenreports the distance of the medical device tip (e.g., cutting and/orcautery tip) allowing the user (e.g., a surgeon) to precisely guide themedical device tip to the tumor. In certain embodiments, prior to anycutting of tissue, the detection component-medical device (21) is movedall around the outside of the patient near the tag in order to calibratethe detection component.

FIG. 8 shows a control unit (60) that is attached to both a remoteactivating device (50) and a detection component-medical device assembly(21). The remote activating device (50) has an excitation coil (55). Thedetection component-surgical device assembly (21) is attached to thecontrol unit (60) via connection wire (65). In certain embodiments, whenthe power of the medical device is activated (e.g., to cut or cauterize)the control unit turns off the magnetic field from the remote activatingdevice, and then turns the magnetic field back on when the power is notactivated on the medical device. In this regard, any magnetic fieldgenerated by the medical device itself does not disturb the magneticfield generated by the remote activating device and vice versa. Thishelp prevent the detection component from picking up false signals (fromthe medical device) that are not related to the location of the tag inthe patient.

Tag Placement

The technology is not limited by the mode of tag placement and a widevariety of placements techniques are contemplated including, but notlimited to, open surgery, laparoscopy, endoscopy, via endovascularcatheter, etc. The tags may be placed by any suitable device, including,but not limited to, syringes, endoscopes, bronchoscopes, extendedbronchoscopes, laparoscopes, thoracoscopes, etc. An exemplary protocolis provided below.

A patient previously identified as having a breast tumor is admitted toa medical facility. The patient is initially sent to radiology. Theradiologist examines prior imaging information identifying the targettumor. The subject is administered a local anesthetic, usually lidocaineor a derivative, using a needle introduced percutaneously. The subjectis positioned in an imaging device, generally either ultrasound,conventional mammography, or a stereotactic unit. The location of thetumor is determined. An introducer needle (usually 6-20 gauge) isinserted either into or just proximal to the tumor and a biopsy needleis placed through the introducer needle and a specimen is obtained usinga variety of methods (suction, mechanical cutting, freezing to fix theposition of the tissue followed by mechanical cutting). After thespecimen is obtained and sent for pathologic examination, a 6-20 gaugetag delivery needle is inserted into the coaxial introducer needle tothe tissue with the distal open end positioned at the lesion. A tag isinserted into the proximal end of the delivery needle and delivered byplunger through the opening at the distal end of the needle and into thetissue. Likewise, the tag could have been pre-positioned at the distalend of the delivery needle. Proper location of the tag is confirmed viaimaging. The delivery needle is withdrawn, leaving the tag in place inthe breast tissue.

This type of procedure can be performed in an analogous manner invirtually any body space, organ, or pathologic tissue with the intent oflocalizing that tissue or space for further diagnosis or treatment ofany kind. Areas of particular interest include but are not limited tothe following organs, and disease processes that take place within them:brain, skull, head and neck, thoracic cavity, lungs, heart, bloodvessels, gastrointestinal structures, liver, spleen, pancreas, kidneys,retroperitoneum, lymph nodes, pelvis, bladder, genitourinary system,uterus, ovaries, and nerves.

Surgical Procedure

The patient is placed onto an operating table with the surgical areaexposed and sterilized. The surgeon is provided with the imaginginformation showing the location of the tumor and tag. An incision ismade at the location of the entry point of the placement needle. Theremote activating device is placed in proximity to the tissue toactivate the tag. The detection component detects a signal from the tagand allow the surgeon to guide the direction medical device toward thetumor. Once the tumor is localized, the surgeon removes the appropriatetissue and removes the tag.

Use of this system and procedure significantly reduces procedure cost,time, and patient inconvenience as compared to wire placement and otherunguided surgeries. Use of the tag reduces the number of imaging stepsrequired and reduces time spent in radiology and surgery. Further, thepatient is not left waiting for surgery with a wire hanging out of theirbody. Avoidance of the wire further reduces pain or discomfortassociated with the pulling on the wire.

In certain embodiments, the detection component is moved around theoutside of the patient, sensing the tag at many different positions tobuild a 3D image of the location of tag within the tissue of thepatient. Such data regarding the scan can, for example, be stored in thedetection component or control unit and then used during a surgicalprocedure to determine the optimal point of entry into the patient'stissue, as well as the angle or angles which are best suited to approachthe tag, and ultimately the associated tumor (e.g., to minimize cuttingof non-target tissue and to maximize the removal of the tumor or tumorsassociated with the tag). Such 3D image scanning (e.g., prior tosurgery) helps achieve the best result for the patient and helps reducethe need for repeating the procedure (e.g., to come back for parts ofthe tumor that were missed on the initial surgery).

In some embodiments, the 3D image generated by moving the detectioncomponent around the location of a tag in a patient is combined with ananother image of the patient with the tag (e.g., generated by MRI, CT,etc.) to generate an image fusion. Combining two or more images of apatient using fiducials as marker points has been described previously(e.g., see, U.S. Pat. No. 7,848,553, and U.S. Pat. Pub. 20030153850,both of which are herein incorporated by reference in their entireties).Commercial image fusion systems include STEALTHSTATION system andPATHFINDER system. Generating image fusions using the detectioncomponent described herein (e.g., where at least one or two implantedtags are used as fiducial points of reference), and then using thedetection device for a procedure on a patient with the tags still inplace, allows for real-time location correction for any movement of thepatient (e.g., via breathing, changed position, organ movement during apacking procedure, etc.). In this regard, in some embodiments, thedetection components herein, and their guidance system (e.g., audible,tactile, or visuals signals) is corrected during a surgical procedure(e.g., in real-time) so the operator is guided appropriately based onany changes in the patient tissue position (e.g., position of a tumor).The tag or tags serve as the fiducial points of reference for both the3D image generated by the detection component, as well as the secondaryimage (e.g., from an MRI or CT image). The tags also then serve asfiducial points of reference during the procedure to orient thedetection device and account for changes in position of the patient. Insome embodiments, the fiducials are implanted in a subject (e.g., inbreast tissue) or be external (e.g., such as placed on each earlobeprior to brain scans and subsequent brain surgery using the detectioncomponent and corresponding surgical device). To see the position, insome embodiments, the tag is used in combination with one or more otherfiducials. For example, one tag in the breast and a sticker containing afiducial on each shoulder. This type of real-time use of image fusionand location information may be used in any type of suitable surgical orablative procedure, including for example, neurosurgery, hepatobiliarysurgery, gynecological surgery, ENT surgery, urological surgery, etc.

In certain embodiments, images (e.g., MRI, CT, etc.) that are generatedfor use with the detection component (and corresponding surgical device)are marked to indicate the location of a target tumor, including asurgical margin around the tumor to ensure complete removal. In someembodiments, a predetermined margin such as 0.5 . . . 1 cm . . . 1.5 cm. . . 2 cm etc., is set around a tumor to ensure removal. The surgicalmargin around a tumor could be set as a sphere, or drawn to correspondto any irregular shape of the tumor (e.g., hand drawn by a doctor on animage to match any irregular shape). In some embodiments, this surgicalmargin around a tumor is used such that, prior to using the detectioncomponent device and corresponding surgical device, one could calibratefor the signal intensity in the x, y and z axis related to this surgicalmargin such that whenever the device reaches a user defined boundary(the predetermined distance from the tumor) something changes, such asan audible, visual, or tactile signal (e.g., a yellow light when a useris at the surgical margin around tumor, and red light when the surgicaldevice has gone within the predetermined surgical margin). In certainembodiments, there could be a signal warning that the surgical device istoo close to the surgical margin (e.g., 5 mm), such as a red warningsignal. In certain embodiments, the tag is placed at or near the tip ofthe surgical instrument or device to track its location (e.g., whetherfused with a medical image or not). For example, the tag could be placedon or near the tip of a nasogastric tube or bladder catheter to confirmthe tip position from outside the patient. Such embodiments, may be usedto improve safety of surgical procedures. Also, in some embodiments, thetag is placed on or near the tip of a vascular catheter, and theposition of the catheter fused to a medical image (CT or MRI) to givethe location of the instrument in the human body. Likewise for anysurgical instrument, catheter, endoscopic instrument, sensing device,biopsy needle, or anything else inserted into the human body where thetip location is important, a tag may be used near or at the tip of suchdevices. In certain embodiments, such as for simple applications, thesecould be unfused and the location determined from outside the body by areader, or in the case of complicated anatomy, the location could besuperimposed on a calibrated image set.

In certain embodiments, the detector component comprises one or morelasers that are directed onto (e.g. projected onto) thesurgical/procedure field (e.g., internal tissue of a patient) as a guideto a the user (e.g., as a guide to the target tumor that is to beresected). In certain embodiments, multiple lasers are used (e.g., allthe same color or providing different colors). Such laser projectiononto the surgical/procedure field allows the user (e.g., physician) tobe guided to the target (e.g., tumor) without the need to look away fromthe surgical or procedure field. In certain embodiments, the detectioncomponent is attached to a curved partially reflective lens that is, forexample, be flipped up for easy viewing of the laser lights on thesurgical field. Such a lens reflects the guiding lights towards theoperator regardless of the orientation of the physician's head and theinstrument surface. Such lens, in some embodiments, are used to decreaseparallax, and improve the viewing angle for the physician.

In certain embodiments, the display for the detection component is notpart of or attached to the detection component, and instead is remote.For example, the display component may be part of a head mounted, suchas Google GLASS or similar devices that present a display close to auser's eye or eyes. In this regard, there may be a wireless connectionbetween the detection component and the display, such as a BLUETOOTHconnection.

We claim:
 1. A method for localizing a tissue region of a patient,comprising: a) placing a remote activating device and a patient inproximity to each other, wherein said remote activating device generatesa magnetic field, and wherein said patient comprises a tag at a locationin, on, or proximal to a tissue of said patient; and b) localizing saidtag in said patient by generating a magnetic field with said remoteactivating device and detecting a signal from said tag using a detectorcomponent, wherein said detector component comprises an electronicscomponent and at least one sense coil and is attached to, or integratedwith, a surgical device, wherein said electronics component comprises asignal processor, and wherein said detector component and said remoteactivating device are separate.
 2. The method of claim 1, wherein saidat least one sense coil comprises at least three sense coils that areseparated from each other by at least 20 mm.
 3. The method of claim 1,wherein said at least one sense coil comprises three sense coilsarranged in a triangle.
 4. The method of claim 1, wherein said remoteactivating device comprises an excitation coil.
 5. The method of claim1, wherein said electronics component comprises: i) a spatialorientation indicator, and/or ii) a distance-to-tag indicator.
 6. Themethod of claim 1, wherein said signal comprises: i) a signal detectableby sensory perception; ii) an interruption or perturbation in saidmagnetic field; or iii) light.
 7. A system comprising: i) a surgicalinstrument comprising a cutting and/or cautery tip, ii) a remoteactivating device that generates a magnetic field, wherein said remoteactivating device comprises a flat pad configured to be positioned undera patient, wherein said flat pad comprises multiple activating coils,wherein each of said activating coils comprises magnet wire wound arounda mandrel, iii) an RFID tag that is insertable at a location in or on atissue of said patient wherein said RFID tag is activated by saidmagnetic field, iv) a control unit comprising a processor and a controlsoftware, wherein said control unit is linked to said remote activatingdevice, and, v) a visual display component configured to display adistance of said cutting or cautery tip to said RFID tag.